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Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280603
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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Brief Summary:

This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia

Design : Randomized, double-blind, active-controlled study

Investigational Product : Finasteride, minoxidil


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: DA-4001C Drug: 5% minoxidil Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arms and Interventions
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Arm Intervention/treatment
Experimental: DA-4001C
DA-4001C is administered
 Drug: DA-4001C
1ml by topical application twice a day
Active Comparator: 5% minoxidil
5% minoxidil is administered
 Drug: 5% minoxidil
1ml by topical application twice a day
Other Name: minoxyl


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram [ Time Frame: baseline and week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram [ Time Frame: Baseline and week 16 ]
  2. Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram [ Time Frame: Baseline, week 16,and week24 ]
  3. Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram [ Time Frame: Baseline, week 16, and week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2

Exclusion Criteria:

  • Evidence of hair loss other than androgenetic alopecia
  • Use of finasteride, dutasteride within previous 12 months
  • Use of minoxidil within previous 6 months
  • Use of androgenic or anti-androgenic agents within previous 6 months
  • Use of steroid agents for local application to scalp or systemic application within previous 1 month
  • History of hair transplantation, scalp reduction
  • Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280603


Locations
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Korea, Republic of
Catholic Medical Center
Seoul, Dongdaemun-gu, Korea, Republic of, 130-709
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Hoon Kang, M.D, Ph.D The catholic univ. of korea, St.Paul's hospital
More Information
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02280603    
Other Study ID Numbers: DA4001_AGAP_POC
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
 Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents